Unless otherwise indicated herein, the materials in this section are not prior art to the claims and are not admitted to be prior art by inclusion in this section.
Photodynamic therapy can be used for the treatment of neoplastic and non-neoplastic diseases. This therapy involves the administration of a photosensitizer, such as a porphyrin, and subsequent irradiation of the cells treated with the photosensitizer at a proper dose and wavelength.
Photofrin® is an FDA-approved porphyrin-based anti-neoplastic agent that accumulates in tumor tissue following systematic administration where it can then be site-specifically irradiated with light at 630 nanometers causing the formation of reactive oxygen species and the death of the surrounding tumor mass. Before being released for clinical use, manufactured lots of Photofrin® must be shown to possess the expected degree of activity, i.e., the potency of the lot must be verified. Lot release assays for biologic drug activity, including potency assays, can either be in vivo or in vitro assays and should measure the activity of the drug thought to be responsible for the clinical effect.